24th Pharmacovigilance 2021
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Event Speakers
WILLIAM WANG
MSD (USA)
TOYIN ADEWOLE
Supernus Pharmaceuticals
TOYIN ADEWOLE
Supernus Pharmaceuticals
TOYIN ADEWOLE, Associate Director of Drug Safety, Supernus Pharmaceuticals (USA)
RAJ BHOGAL
Jazz Pharmaceuticals
RAJ BHOGAL
Jazz Pharmaceuticals
RAJ BHOGAL, Senior Director, R&D Audits & Inspections, Jazz Pharmaceuticals
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Deepa is an Experienced Clinical Development and Drug Safety physician. She served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities. Currently she is the Chief Executive Officer of Clinexel Life Sciences Pvt Ltd.
CLINEXEL is an agile, customer focused full service, Clinical Research Organization, that provides clinical research, pharmacovigilance, regulatory, auditing and medical writing services to pharma, biotech and medical device companies. At CLINEXEL, our mission is to partner with early-stage pharma and biotech companies for fast and efficient clinical development of their innovations.
MICHAEL BEAN
Johnson & Johnson
MICHAEL BEAN
Johnson & Johnson
MICHAEL BEAN, Senior Director, BioResearch Regulatory, Compliance, Johnson & Johnson
OYINKANSOLA O
Supernus Pharmaceuticals
OYINKANSOLA O
Supernus Pharmaceuticals
OYINKANSOLA ODEBO, Assistant Director, Drug Safety Clinical, Research, Supernus Pharmaceuticals
DAVID JEFFERYS
Eisai
DAVID JEFFERYS
Eisai
DAVID JEFFERYS, Senior VP Regulatory, Eisai
David is currently Senior Vice president in Eisai, responsible for Global Regulatory, Government Relations, Public Affairs and Product Safety. After qualifying in medicine, he practised as a physician and cardiologist, with additional interests in metabolic medicine and clinical toxicology. He spent 21 years as a senior regulatory in the UK and Europe. He was executive director of licensing in MCA, CPMP member, chairman of the MRFG and PER committees. He was CEO and Director of the UK Medical Devices Agency and on the creation of the MHRA acting joint chief executive. He worked on secondment at the EMEA /EMA on benefit risk methodologies.
Since 2005 he has worked for Eisai, currently he is also chairman of the ABPI Regulatory Science Committee regulatory committee and a member of the Innovation Board.Within EFPIAhe chairs the Regulatory Committee and sits on the International Regulatory Board.
Chairman of the IFPMA Regulatory Science Committee, a member of the IFPMA Council and of the ICH Committee and General Assembly.
He is a past chairman of the CMR Advisory Board and currently sits as a member of the CIRS Scientific Advisory Council.
JOHN POUSTIE
Norgine
SAKHARAM G
Renovare Healthcare
MARY LYNNE V P
World Federation for Incontinent Patients – WFIP
MARY LYNNE V P
World Federation for Incontinent Patients – WFIP
MARY LYNNE VAN POELGEEST-POMFRET, International Patient Advocate, World Federation for Incontinent Patients – WFIP
WIVINA DE W
Alexion Pharmaceuticals
WIVINA DE W
Alexion Pharmaceuticals
WIVINA DE WAELE, Director EMEA, Global Drug Safety, Alexion Pharmaceuticals
ALESSANDRO V
MSD (CH)
ALESSANDRO V
MSD (CH)
ALESSANDRO VAGHEGGINI, Associate Principal Biostatistician, Clinical, Safety Statistics, MSD (CH)
JAYLAXMI N
Lupin
KHAUDEJA BANO
Roche - Genentech (USA)
KHAUDEJA BANO
Roche - Genentech (USA)
KHAUDEJA BANO, Vice President - Global Head of Device Quality, Roche - Genentech (USA)
• Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.
• Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, AbbVie Inc and Amgen. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and
combination products.
• She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
BEN LOCWIN
Black Diamond Networks
SHAUN COMFORT
Roche - Genentech
SHAUN COMFORT
Roche - Genentech
SHAUN COMFORT, Principal Scientific Enablement Director, Roche - Genentech
ROSALINA D
Sanofi
ROSALINA D
Sanofi
ROSALINA DOMIN, Senior Director, QA and Deviation Management Head PV Quality, Sanofi
AMGAD SHEBL
CSL Behring
AMGAD SHEBL
CSL Behring
AMGAD SHEBL, Sr. Director, Global Safety Lead, Immunology, Global Clinical Safety & PV, CSL Behring
JESSICA SANTOS
KANTAR HEALTH
GAURI UTTURKAR
Glenmark Pharmaceuticals
GAURI UTTURKAR
Glenmark Pharmaceuticals
GAURI UTTURKAR, Senior Manager - Pharmacovigilance, Glenmark Pharmaceuticals
SUMIT MUNJAL
Takeda Pharmaceuticals
SUMIT MUNJAL
Takeda Pharmaceuticals
SUMIT MUNJAL, Vice President, Global Patient Safety Evaluation, Takeda Pharmaceuticals
MIRCEA CIUCA
CSL Behring
MIRCEA CIUCA
CSL Behring
MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical, Safety & PV, CSL Behring
GHASSAN KARAM
WHO
GHASSAN KARAM
WHO
GHASSAN KARAM, Project Manager, International Clinical Trials, Registry Platform (ICTRP), WHO
OMPRAKASH S.S
FDA (Maharashtra state)
OMPRAKASH S.S
FDA (Maharashtra state)
OMPRAKASH S. SADHWANI, Former Joint Commissioner and Controlling Authority, FDA (Maharashtra state)
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”
Event Schedule
Meet and to network with your conference colleagues.
09:30 – Welcome Address & Virtual Conference Platform Instructions
MARKET TRENDS & WAY FORWARD
09:40 – ICTRP project and the COVID-19 clinical trials
GHASSAN KARAM, Project Manager - International Clinical Trials Registry Platform (ICTRP), World Health Organization (WHO)
10:20 - ‘IMI ConcePTION: Building an ecosystem for generating, and providing evidence on the safety of medicines in pregnancy & breastfeeding’
Every woman has the right to safe & effective use of medicines, based on scientific evidence, especially when she is making a decision for two. But the current situation is unsatisfactory, because:
• Scientific evidence of the use of medicines in pregnancy and during breastfeeding is lacking, incomplete or unavailable in the public domain
• No harmonised infrastructure exists;
• There is fragmentation and inconsistencies regarding advice and knowledge
• The situation is not sustainable
• IMI ConcePTION aims to address these problems
DAVID J LEWIS, EU QPPV Head QPPV Office, Novartis
11:00 – Morning Coffee/Tea & Discussion
11:20 – Keynote Panel Discussion: Improvising the PV ecosystem for betterment
• During the pandemic - Complications associated with Pharmacovigilance (PV) procedures.
• What are the market opportunities, market risk and market overview of the Pharmacovigilance (PV) market?
• Documentation (RMPs, PSURs, PADERs, PBRERs)
• Outsourcing in Pharmacovigilance- Best Practices, Challenges and key consideration
• Pharmacy practice and its guidelines
• Importance of Proper communication - Sponsor – Site – CRO & Patients
• Possible impacts of Brexit
Moderator
DEEPA ARORA, Director, CLINEXEL Life Sciences
Panellists
SUMIT MUNJAL, Global Director, PV & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda
TOYIN ADEWOLE, Associate Director of Drug Safety, Supernus Pharmaceuticals (USA)
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA
ANDREA OLIVA, Head of Pharmacovigilance, Italy, Viatris
12:10 – Quality, Safety & Signal Detection – What does the future hold?
• Strategies for best practice in Signal Detection
• Exploring patient support and marketing research programs from a safety perspective
• How should we approach?
• Using technology to enhance interactive connection with patients
• Statistical signal detection as a routine pharmacovigilance practice
• Latest updates and hot topics
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare Solution
12:50 – Networking luncheon
REGULATORY OVERVIEW & UPDATE
13:50 – Panel Discussion – PV - Regulatory Updates
• Impact of the pandemic
• Key current changes and their impact on current PV
• Impact of Brexit – Regulatory aspect
• Future Legislation: Pharmacovigilance – Industry Vision
• PV System Legislation Updates
• Outsourcing – Key areas to look out while outsourcing
• Enhancing communication between regulators, regional authorities and patients
Moderator
BEN LOCWIN, Executive SME, Black Diamond Networks
Panellists
DAVID JEFFERYS, Sr. VP Regulatory, Eisai
MICHAEL BEAN, Senior Director, Regulatory Compliance R&D, Johnson & Johnson
YUUNG YUUNG YAP, Assistant General Counsel, Global Legal Regulatory, Viatris
14:40 – Drug Safety and Pharmacovigilance processes: Ensuring a smooth and accurate workflow
OYINKANSOLA ODEBO, Assistant Director, Drug Safety Clinical Research, Supernus Pharmaceuticals (USA)
15:10 - Afternoon Tea/Coffee
15:30 - How to ensure quality of PV deliverables
• What quality checks are really needed?
• Key Metrics and KPIs
• Proactive Quality Management
• Relationship with PV stakeholders
ROSALINA DOMIN, Senior Director, QA and Deviation Management Head, PV Quality, Sanofi
DATA COLLECTION – MANAGEMENT
16:00 – Panel Discussion - PV Audit & Inspections – Keeping on the right side of Inspectors
• Key international legislation and guidelines covering PV Quality Management, including PV audits and PV in spections
• Creating and maintaining a risk based PV audit algorithm – and a corresponding audit program
• Design and implement appropriate and effective corrective and preventive actions
• Always prepared for a regulatory PV inspection
• Data management is a key principle of pharmacovigilance
• Risk based selection criteria for auditing
• Relationship to other GxPs
Moderator
VALENTINA MANCINI, Director PV, EU QPPV, Shionogi Europe
Panellists
TEA BABIC, Director – Audits and Inspections, Teva
RAJ BHOGAL, Senior Director, R&D Audits & Inspections, Jazz Pharmaceuticals
JAYLAXMI NALAWADE, Associate Director - Pharmacovigilance & REMS, Lupin
LISBETH TOFTE HEMMINGSEN, Director, Drug Safety Consult
16:50 - End of the conference
IMPACT OF TECHNOLOGY
09:40 – Future Pharmacovigilance Systems: Adoption of emerging technologies
• Artificial intelligence/Machine learning in Pharmacovigilance
• Can PV keep up with the pace of innovation?
• Are stakeholders and PV systems ready to embrace AI ?
• Information technology in pharmacovigilance
• Decision process
MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical Safety and, Pharmacovigilance, CSL Behring
10:20 – Outsourcing in Pharmacovigilance - Best Practices, Challenges and key consideration
JOHN POUSTIE, Senior Director, Global Pharmacovigilance, Norgine
11:00 – Morning Coffee/Tea & Discussion
PATIENT SAFETY
11:20 – Keynote Panel Discussion : Patient Centric - Pharmacovigilance & Patient Safety
• Driving patient centricity into your PV plans
• Challenges for safety reporting activities due to the COVID-19 pandemic
• Pharmacovigilance as a tool for safety and monitoring
• Pharmacovigilance and assessment of drug safety reports during COVID 19
• Patient-Perspectives in Benefit-Risk Assessments
• Adapting operations to changing conditions
• Leveraging technology to transform patient safety
• Next generation pharmacovigilance for enhanced patient safety
Moderator
BEN LOCWIN, Executive SME, Black Diamond Networks
Panellists
WIVINA DE WAELE, Director, Regional Safety Excellence EMEA.Global Drug, Safety, Alexion Pharmaceuticals
MARY LYNNE VAN POELGEEST, President, World Federation for Incontinent Patients - (WFIP)
SUE REES, Pharmacovigilance Expert, (Former EU QPPV, Executive Director, Global Safety, Amgen)
AMGAD SHEBL, Director, Global Clinical Safety & PV / Clinical R&D, CSL Behring
NICOLE BAKER, Co-Founder, BioLogit
12:10 – Battle Between PV Safety Data Collection with Data Protection Restrictions
• PV needs most comprehensive data for safety database, yet data protection legislation only allow data minimisation and only collect what is necessary. Both sides are pushed by legislation with hefty enforcement, what shall practitioners do?
• An international DP landscape is presented with historical changes and cases review
JESSICA SANTOS, Global Compliance & Quality Director, KANTAR HEALTH
12:50 – Networking luncheon
RISK MANAGEMENT & PLANNING
3:50 – Panel Discussion – PV – Risk Management & Planning
• Global approach to good pharmacovigilance and risk management
• Risk management in the lifecycle of a drug
• How effective is your risk management?
• Implementation and maintenance of RMP’s – Overcoming its challenges
• Risk management in different jurisdictions
• Benefit/Risk ratio: the common denominator
• Research and development improvement
Moderator
MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical Safety and Pharmacovigilance, CSL Behring
Panellists
GAURI UTTURKAR, Senior Manager - Pharmacovigilance, Glenmark Pharmaceuticals
CHETAN SHATAPATHY, Principal Pharamcovigilance Physician - Oncology R&D Unit, AstraZeneca
RUDI SCHEERLINCK, PV Risk management - clinical studies, Galderma
MANOJ SWAMINATHAN, DGM/Head - Global Pharmacovigilance & Global Medical Information, Piramal
QUALITY - SAFETY – SIGNAL DETECTION
14:40 – A PV Organization’s Transformational Journey Towards Combination Product Safety
• Discuss the changing environment of post marketing safety and factors driving the change
• Key challenges and recommended best practices for the PV organizational transformation
• How has the role of PV and the definition of Safety and Risk evolved to support Combination product safety
KHAUDEJA BANO, Executive Medical Director, Combination Product Safety Head, Amgen (USA)
15:20 - Afternoon Tea/Coffee
15:40 – Safety Evaluation in Master Protocols
• Aggregate safety assessment planning and monitoring
• Statistical considerations in multi-cohort and multi-arm studies
• Safety evaluation with statistical multiplicity considerations
WILLIAM WANG, Executive Director, MSD (USA)
ALESSANDRO VAGHEGGINI, Associate Principal Biostatistician, Clinical Safety Statistics, MSD (CH)
JAMES BUCHANAN, President, Covilance
JINGJING YE, Senior Director, BeiGene
16:30 - How Good Are You? Documenting and Analyzing Human Causality Performance in PV
• How to perform comparative analysis of causality assessments of Drug-Event-Pairs
• Common metrics and results for Human Expert causality assessments from the medical literature
• Future directions - simple steps to improving causality assessments
SHAUN COMFORT, Principal Scientific Enablement Director, Roche - Genentech
17:00 - End of the conference
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Testimonials
Biocon PV Lead
Pfizer Country Safety Lead UK & Ireland
Takeda Regulatory Inspection Lead, Safety & International Global Quality
CSL Behring Director, Clinical Safety Physician
Presentation
